Upstream Manufacturing Associate

We are seeking an experienced Upstream Manufacturing Scientist to support the execution of cell culture processes and bioreactor operations at scales ranging from 50 L to 1000 L. This role is based within a cGMP environment and involves producing engineering and clinical batches.

The ideal candidate will have a strong technical foundation in cell biology and bioreactor operations, with experience in initiating and managing documentation such as batch records, protocols, and investigations.

Key Responsibilities

• Execute upstream production batches alongside a collaborative team of manufacturing associates and engineers.
• Operate mammalian cell culture and bioreactor systems at various scales.
• Maintain compliance with cGMP requirements throughout manufacturing activities.
• Contribute to the improvement of manufacturing techniques and equipment specifications.
• Monitor process data and make necessary on-line adjustments.
• Review executed batch records and associated documentation.
• Support investigations and corrective actions related to batch execution issues.
• Ensure adherence to environmental health and safety standards.
• Perform additional tasks as assigned in line with manufacturing goals.

Qualifications

• Bachelor’s or Master’s degree in Chemical Engineering, Biology, Biochemistry, or related field.
• Minimum of 3 years of relevant experience within a biopharmaceutical or GMP manufacturing environment.
• Strong understanding of upstream bioprocesses and cGMP regulations.
• Hands-on experience with single-use bioprocessing systems, including bags, manifolds, columns, and tubing assemblies.
• Proficiency in documentation, investigations, and continuous process improvement.

Key Skills

• Effective written and verbal communication.
• Ability to work independently and collaboratively.
• Proficient in Microsoft Word, Excel, and general data handling.
• Detail-oriented with strong organizational skills.
• Familiarity with cleaning validation and GMP documentation review.